A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement
Primary Purpose
Wounds and Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
V.A.C.Ulta with Prontosan instillation
V.A.C.Ulta without instillation
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries
Eligibility Criteria
Inclusion Criteria:
The Subject:
- has a wound prior to informed consent
- will be admitted as an inpatient
- is >= 18 years of age at time of consent
- is able to provide his/her own informed consent
- is willing and able to return for all scheduled and required study visits
- has an open wound >= 4cm in any plane of measurement excluding tunnels after initial surgical debridement
- has a wound that is appropriate for NPWT according to approved indications for use
- has not participated in a clinical trial within the past 30 days
- has a 30 day wound history available if the wound has been previously treated
Exclusion Criteria:
The Subject:
- is pregnant as determined by a positive serum or urine pregnancy test at the time of screening
- has a life expectancy of < 12 months
- is not healthy enough to undergo surgery for any reason
- has, in the investigator's opinion, any clinically significant condition that would impair the participant's ability to comply with the study procedures
- has, in the opinion of the investigator, a condition that will not allow the subject to tolerate the therapy (e.g. painful conditions such as vasculitis)
- has rheumatoid arthritis
- has a bleeding disorder or coagulopathy
- has a wound that contains antibiotic cement or beads
- has an ischemic lower extremity wound as determined by lack of detectable pulses in the extremity or ankle-brachial pressure indices of < 0.9 with a history of diabetes, or < 0.6 if the subject is non-diabetic
- has a known allergy or hypersensitivity to V.A.C. Therapy dressing components including polyurethane or polyvinyl alcohol (drape and foam), or materials that contain acrylic adhesive (drape adhesive)
- has a known allergy or hyper sensitivity to 3M Cavilon No Sting Barrier Film or any of its components including Hexamethyldisiloxane, isooctane, acrylate terpolymer, polyphenylmethysiloxane, copolymer
- has a know allergy or hypersensitivity to Prontosan or any of its components including polyhexamethylene biguanide (PHMB), or undecylenamidopropyl betaine
- has received NPWT on the study wound within the last 30 days
has a wound that is contraindicated with Prontosan
a. presence of hyaline cartilage in the wound
has a wound that is contraindicated with V.A.C. Therapy including:
- malignancy in the wound
- untreated osteomyelitis
- non-enteric or unexplored fistulas
- necrotic tissue with eschar remaining in the wound after debridement (NOTE: Once necrotic tissue or eschar is removed from the wound bed, subjects may be included)
- unprotected, exposed blood vessels, anastomotic sites, organs, or nerves in direct contact with foam
- use of intervening layers between the wound bed and foam
has a wound that is contraindicated with V.A.C. VeraFlo Therapy including:
- Thoracic or abdominal cavities
- Unexplored wounds that may communicate with adjacent body cavities
- has a wound that is closed after the initial debridement
Sites / Locations
- Medstar Georgetown University Hospital
- University of Miami Miller School of Medicine
- Northwestern University
- Brigham and Women's Hospital
- St. Luke's University Hospital
- University of Pennsylvania Health System
- University of Texas Southwestern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
V.A.C.Ulta with Prontosan instillation
V.A.C.Ulta without instillation
Arm Description
Treatment Arm
Control Arm
Outcomes
Primary Outcome Measures
Number of Inpatient Operating Room Debridements
Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room
Secondary Outcome Measures
The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01867580
Brief Title
A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement
Official Title
A Prospective, Randomized, Multi-Center Trial Evaluating the Effectiveness of the V.A.C. Ulta Negative Pressure Wound Therapy System With V.A.C. VeraFlo Dressing System in Operatively Debrided Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine the effectiveness of the Veraflo with Prontosan vs VAC in wounds that require operative debridement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
V.A.C.Ulta with Prontosan instillation
Arm Type
Experimental
Arm Description
Treatment Arm
Arm Title
V.A.C.Ulta without instillation
Arm Type
Active Comparator
Arm Description
Control Arm
Intervention Type
Device
Intervention Name(s)
V.A.C.Ulta with Prontosan instillation
Intervention Description
NPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution)
Intervention Type
Device
Intervention Name(s)
V.A.C.Ulta without instillation
Intervention Description
NPWT only
Primary Outcome Measure Information:
Title
Number of Inpatient Operating Room Debridements
Description
Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room
Time Frame
until the wound is deemed ready for closure or coverage by the investigator up to 64 days
Secondary Outcome Measure Information:
Title
The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis.
Time Frame
Immediately following initial post debridement to the first dressing change up to 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The Subject:
has a wound prior to informed consent
will be admitted as an inpatient
is >= 18 years of age at time of consent
is able to provide his/her own informed consent
is willing and able to return for all scheduled and required study visits
has an open wound >= 4cm in any plane of measurement excluding tunnels after initial surgical debridement
has a wound that is appropriate for NPWT according to approved indications for use
has not participated in a clinical trial within the past 30 days
has a 30 day wound history available if the wound has been previously treated
Exclusion Criteria:
The Subject:
is pregnant as determined by a positive serum or urine pregnancy test at the time of screening
has a life expectancy of < 12 months
is not healthy enough to undergo surgery for any reason
has, in the investigator's opinion, any clinically significant condition that would impair the participant's ability to comply with the study procedures
has, in the opinion of the investigator, a condition that will not allow the subject to tolerate the therapy (e.g. painful conditions such as vasculitis)
has rheumatoid arthritis
has a bleeding disorder or coagulopathy
has a wound that contains antibiotic cement or beads
has an ischemic lower extremity wound as determined by lack of detectable pulses in the extremity or ankle-brachial pressure indices of < 0.9 with a history of diabetes, or < 0.6 if the subject is non-diabetic
has a known allergy or hypersensitivity to V.A.C. Therapy dressing components including polyurethane or polyvinyl alcohol (drape and foam), or materials that contain acrylic adhesive (drape adhesive)
has a known allergy or hyper sensitivity to 3M Cavilon No Sting Barrier Film or any of its components including Hexamethyldisiloxane, isooctane, acrylate terpolymer, polyphenylmethysiloxane, copolymer
has a know allergy or hypersensitivity to Prontosan or any of its components including polyhexamethylene biguanide (PHMB), or undecylenamidopropyl betaine
has received NPWT on the study wound within the last 30 days
has a wound that is contraindicated with Prontosan
a. presence of hyaline cartilage in the wound
has a wound that is contraindicated with V.A.C. Therapy including:
malignancy in the wound
untreated osteomyelitis
non-enteric or unexplored fistulas
necrotic tissue with eschar remaining in the wound after debridement (NOTE: Once necrotic tissue or eschar is removed from the wound bed, subjects may be included)
unprotected, exposed blood vessels, anastomotic sites, organs, or nerves in direct contact with foam
use of intervening layers between the wound bed and foam
has a wound that is contraindicated with V.A.C. VeraFlo Therapy including:
Thoracic or abdominal cavities
Unexplored wounds that may communicate with adjacent body cavities
has a wound that is closed after the initial debridement
Facility Information:
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
St. Luke's University Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement
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